| 1. |
- De Maria, C., et al.
(författare)
-
The UBORA E-Infrastructure for Open Source Innovation in Medical Technology
- 2020
-
Ingår i: XV Mediterranean Conference on Medical and Biological Engineering and Computing – MEDICON 2019. - Cham : Springer. ; , s. 878-882
-
Konferensbidrag (refereegranskat)abstract
- The development of medical devices with open source and collaborative design methodologies has the potential to increase the access to medical technologies, thanks to a feasible reduction of design, management, maintenance, and repairing costs linked to the open access of device blueprints. UBORA is an e-infrastructure for the co-design of open source medical devices, which promotes the compliance with internationally recognized quality standards and regulations for safety and efficacy of devices, taking the EN ISO 13485:2016 and the EU MDR 2017/745 as inspiration. UBORA guides the user through a systematic design process, from the identification of clinical needs, of risks class and relevant standards for the device, and provides project management tools, including a repository, finalized to the preparation of the pre-production device dossier. The process is supervised by expert mentors, which ensure that safety and efficacy criteria are fulfilled. The UBORA e-infrastructure is in line with the 2030 Agenda for the Sustainable Development Goals, promoting and strengthening the initiatives of an international community of designers, healthcare providers and policy-makers, toward the reduction of inequalities in the access to medical devices.
|
|
| 2. |
- Ahluwalia, A., et al.
(författare)
-
Towards open source medical devices current situation, inspiring advances and challenges
- 2018
-
Ingår i: BIODEVICES 2018 - 11th International Conference on Biomedical Electronics and Devices, Proceedings; Part of 11th International Joint Conference on Biomedical Engineering Systems and Technologies, BIOSTEC 2018. - : SciTePress. - 9789897582776 ; , s. 141-149
-
Konferensbidrag (refereegranskat)abstract
- Open Source Medical Devices may be part of the solution towards the democratization of medical technologies pursuing Universal Health Coverage as part of the Sustainable Development Goals for United Nations. Recent technological advances, especially in information and communication technologies, combined with innovative collaborative design methodologies and manufacturing techniques allow for the mass-personalization of biodevices and help to optimize the related development times and costs, while keeping safety in the foreground through the whole life cycle of medical products. These advantages can be further promoted by adequately fostering collaboration, communication, high value information exchange, and sustainable partnerships and by extending the employment of open source strategies. To this end, within the UBORA project, we are developing a framework for training the biomedical engineers of the future in open-source collaborative design strategies and for supporting the sharing of information and the assessment of safety and efficacy in novel biodevices. An essential part of this open-source collaborative framework is the UBORA e-infrastructure, which is presented in this study, together with some initial success cases. Main future challenges, connected with regulatory harmonization, with educational issues and with accessible and open design and manufacturing resources, among others, are also presented and discussed.
|
|
